Investigation the effect of trehalose on function of an ALS patient
Design
This trial is a before-after trial without a control group and will be performed by participation of only one eligible patient.
Settings and conduct
This study will be conducted in Ghaem Hospital in Mashhad. In the current trial, one ALS patient who meets the inclusion criteria, will receive IV trehalose (15 gr per week) for 12 weeks. The mentioned outcomes will be compared before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patient with ALS diagnosis (according to Gold Coast criteria), Obtaining the score of 0, 1, or 2 in each ALS-FRS item, Satisfaction for participation in the research project.
Exclusion Criteria: Uncontrolled and severe adverse event.
Intervention groups
Intervention group: IV Trehalose (15 g per week) for 12 weeks by Dr.Rajabi Pharmaceutical Co.
Main outcome variables
Primary outcome: Patient`s Function (assessed by ALS-FRS revised questionnaire).
Secondary outcomes: Evaluating the lung function (spirometry), IL-6 and C-Reactive Protein (CRP).
All the mentioned outcomes will be assessed at baseline and after 3 months.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181022041407N6
Registration date:2024-06-13, 1403/03/24
Registration timing:prospective
Last update:2024-06-13, 1403/03/24
Update count:0
Registration date
2024-06-13, 1403/03/24
Registrant information
Name
Maryam Emadzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9262
Email address
emadzadehm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of trehalose on function of an ALS patient
Public title
Investigation the effect of trehalose on ALS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with ALS diagnosis (according to Gold Coast criteria)
Obtaining the score of 0, 1, or 2 in each ALS-FRS item
Satisfaction for participation in the research project
Exclusion criteria:
Uncontrolled and severe adverse event
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
1
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of School of Medicine at Mashhad University of Medical Sciences
Street address
Faculty of Medicine, University Campus, Azadi Square